The FDA Report on Intraocular Lenses

Walter J. Stark; David M. Worthen; Jack T. Holladay; Patricia E. Bath; Mary E. Jacobs; George C. Murray; Eleanor T. McGhee; Max W. Talbott; Melvin D. Shipp; Nancy E. Thomas; Roger W. Barnes; Daniel W.C. Brown; Jorge N. Buxton; Robert D. Reinecke; Chang Sheng Lao; Scarlett Fisher

doi:10.1016/S0161-6420(83)34555-3

The FDA Report on Intraocular Lenses

Walter J. Stark, David M. Worthen, Jack T. Holladay, Patricia E. Bath, Mary E. Jacobs, George C. Murray, Eleanor T. McGhee, Max W. Talbott, Melvin D. Shipp, Nancy E. Thomas, Roger W. Barnes, Daniel W.C. Brown, Jorge N. Buxton, Robert D. Reinecke, Chang Sheng Lao, Scarlett Fisher

Research output: Contribution to journal › Article › peer-review

167 Scopus citations

Abstract

Clinical studies of intraocular lenses (IOLs) as investigational devices have been regulated in the United States by the Food and Drug Administration (FDA) since February 9, 1978. As of August 1982, data have been collected on more than one million IOLs implanted. During the last 12 months of the study, 409,000 IOLs were implanted. Visual acuity of 20/40 or better at one year after surgery was present in 85% of over 45,000 cases reviewed. Increasing patient age, surgical problems, postoperative complications, and adverse reactions were factors that reduced the visual acuity. The current trend in the USA is for implantation of the posterior chamber and anterior chamber IOLs.

Original language	English (US)
Pages (from-to)	311-317
Number of pages	7
Journal	Ophthalmology
Volume	90
Issue number	4
DOIs	https://doi.org/10.1016/S0161-6420(83)34555-3
State	Published - 1983
Externally published	Yes

Keywords

U.S. Food and Drug Administration (FDA)
cataract
intraocular lenses
pseudophakos

ASJC Scopus subject areas

Ophthalmology

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10.1016/S0161-6420(83)34555-3

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@article{a06cb3a4124d43389b8e13e6552289b2,

title = "The FDA Report on Intraocular Lenses",

abstract = "Clinical studies of intraocular lenses (IOLs) as investigational devices have been regulated in the United States by the Food and Drug Administration (FDA) since February 9, 1978. As of August 1982, data have been collected on more than one million IOLs implanted. During the last 12 months of the study, 409,000 IOLs were implanted. Visual acuity of 20/40 or better at one year after surgery was present in 85% of over 45,000 cases reviewed. Increasing patient age, surgical problems, postoperative complications, and adverse reactions were factors that reduced the visual acuity. The current trend in the USA is for implantation of the posterior chamber and anterior chamber IOLs.",

keywords = "U.S. Food and Drug Administration (FDA), cataract, intraocular lenses, pseudophakos",

author = "Stark, {Walter J.} and Worthen, {David M.} and Holladay, {Jack T.} and Bath, {Patricia E.} and Jacobs, {Mary E.} and Murray, {George C.} and McGhee, {Eleanor T.} and Talbott, {Max W.} and Shipp, {Melvin D.} and Thomas, {Nancy E.} and Barnes, {Roger W.} and Brown, {Daniel W.C.} and Buxton, {Jorge N.} and Reinecke, {Robert D.} and Lao, {Chang Sheng} and Scarlett Fisher",

year = "1983",

doi = "10.1016/S0161-6420(83)34555-3",

language = "English (US)",

volume = "90",

pages = "311--317",

journal = "Ophthalmology",

issn = "0161-6420",

publisher = "Elsevier Inc.",

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T1 - The FDA Report on Intraocular Lenses

AU - Stark, Walter J.

AU - Worthen, David M.

AU - Holladay, Jack T.

AU - Bath, Patricia E.

AU - Jacobs, Mary E.

AU - Murray, George C.

AU - McGhee, Eleanor T.

AU - Talbott, Max W.

AU - Shipp, Melvin D.

AU - Thomas, Nancy E.

AU - Barnes, Roger W.

AU - Brown, Daniel W.C.

AU - Buxton, Jorge N.

AU - Reinecke, Robert D.

AU - Lao, Chang Sheng

AU - Fisher, Scarlett

PY - 1983

Y1 - 1983

N2 - Clinical studies of intraocular lenses (IOLs) as investigational devices have been regulated in the United States by the Food and Drug Administration (FDA) since February 9, 1978. As of August 1982, data have been collected on more than one million IOLs implanted. During the last 12 months of the study, 409,000 IOLs were implanted. Visual acuity of 20/40 or better at one year after surgery was present in 85% of over 45,000 cases reviewed. Increasing patient age, surgical problems, postoperative complications, and adverse reactions were factors that reduced the visual acuity. The current trend in the USA is for implantation of the posterior chamber and anterior chamber IOLs.

AB - Clinical studies of intraocular lenses (IOLs) as investigational devices have been regulated in the United States by the Food and Drug Administration (FDA) since February 9, 1978. As of August 1982, data have been collected on more than one million IOLs implanted. During the last 12 months of the study, 409,000 IOLs were implanted. Visual acuity of 20/40 or better at one year after surgery was present in 85% of over 45,000 cases reviewed. Increasing patient age, surgical problems, postoperative complications, and adverse reactions were factors that reduced the visual acuity. The current trend in the USA is for implantation of the posterior chamber and anterior chamber IOLs.

KW - U.S. Food and Drug Administration (FDA)

KW - cataract

KW - intraocular lenses

KW - pseudophakos

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AN - SCOPUS:0020536626

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VL - 90

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EP - 317

JO - Ophthalmology

JF - Ophthalmology

IS - 4

ER -

The FDA Report on Intraocular Lenses

Abstract

Keywords

ASJC Scopus subject areas

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